CSMS 49059465·Operational·August 13, 2021·View on csms.cbp.gov ↗

FDA Deployment 9/4/21: New FDA Validations Which May Result in Rejects and Implementation of New Sub

Plain-English explanation

CSMS 49059465 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (operational), published on August 13, 2021. It carries the official CBP guidance brokers and importers must follow for the topic — "FDA Deployment 9/4/21: New FDA Validations Which May Result in Rejects and Implementation of New Sub". CSMS messages are the operational layer between Commerce determinations and at-the-border collections: when Commerce publishes a new rate, scope ruling, or instruction, CBP turns it into a CSMS that ACE/ACS systems and brokers act on.

Message body

Full text as published by U.S. Customs and Border Protection

CSMS #49059465 - FDA Deployment 9/4/21: New FDA Validations Which May Result in Rejects and Implementation of New Sub-Reason Code U.S. Customs and Border Protection sent this bulletin at 08/13/2021 09:07 AM EDT Cargo Systems Messaging Service CSMS #49059465 - FDA Deployment 9/4/21: New FDA Validations Which May Result in Rejects and Implementation of New Sub-Reason Code On September 4, 2021 the U.S. Food and Drug Administration (FDA) will deploy the following: • A validation to check the syntax of the email transmitted in PG21 for the FSV entity. If a valid FSV email syntax is not transmitted, the entry will be rejected. (Related: CSMS #48912861 ) • A validation to allow only one Product Code Qualifier and one Product Code Number in PG02for a given FDA line. If an FDA line is received with multiple Product Code Qualifiers and/or multiple Product Code Numbers, the entry will be rejected. (Related: CSMS #46970234 ) • Implementation of new sub-reason 187 (SECOND AND FINAL REQUEST FOR INFORMATION) under reason code 25 (ADDITIONAL VERIFICATION NEEDED). The new sub-reason 187 will be sent to filers with an open document request that exceeds 72 hours from the initial request for documents. Filers or importers are encouraged to submit documents via ITACS in order to prevent this additional SO message. This change will be applied to all current open document requests older than 72 hours. (Related: CSMS #47756187 ) For further assistance on this deployment or FDA ACE technical inquiries, contact FDA ACE Support, 877-345-1101, ACE_Support@fda.hhs.gov . ACE Support Hours: Monday - Friday, 8AM-8PM ET. Related messages: CSMS #48912861 , CSMS #46970234 , CSMS #47756187 Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page . You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com . This service is provided to you at no charge by U.S. Customs and Border Protection . Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes. Powered by Privacy Policy | Cookie Statement | Help

Frequently asked questions

What is CSMS 49059465?

CSMS 49059465 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "FDA Deployment 9/4/21: New FDA Validations Which May Result in Rejects and Implementation of New Sub". CSMS bulletins are the operational instructions CBP issues to brokers, importers, and ACE filers covering rate changes, system updates, scope guidance, and other day-to-day customs-operations changes.

When was CSMS 49059465 published?

CBP published CSMS 49059465 on August 13, 2021. The bulletin's instructions are typically operative as of the publication date unless the body specifies a different effective date.

Is the CBP CSMS the legally binding instruction?

Yes — for at-the-border filing and entry collection. CSMS messages translate Commerce's Federal Register determinations into operational CBP instructions that ACE/ACS systems and brokers execute. The Federal Register notice is the underlying legal authority; the CSMS is the operational implementation. Both should be read together when reconciling a rate or scope change.

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